Meta-Analysis for the Pooled Sensitivity and Specificity of Hepatitis B Surface Antigen Rapid Tests

Sang-Hyun Hwang; Heung-Bum Oh; Sung-Eun Choi; Hyung-Hoi Kim; Chulhun L Chang; Eun-Yup Lee; Han-Chul Son

doi:10.3343/kjlm.2008.28.2.160

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Hwang, Oh, Choi, Kim, Chang, Lee, and Son: Meta-Analysis for the Pooled Sensitivity and Specificity of Hepatitis B Surface Antigen Rapid Tests

Original Article

Korean J Leg Med 2008;28(2):160-168.

Published online: 14 February 2008

DOI: https://doi.org/10.3343/kjlm.2008.28.2.160

Meta-Analysis for the Pooled Sensitivity and Specificity of Hepatitis B Surface Antigen Rapid Tests

Sang-Hyun Hwang, M.D.^1,², Heung-Bum Oh, M.D.³, Sung-Eun Choi³, Hyung-Hoi Kim, M.D.^1,², Chulhun L Chang, M.D.^1,², Eun-Yup Lee, M.D.^1,², Han-Chul Son, M.D.^1,²

¹Department of Laboratory Medicine, Pusan National University School of Medicine, Busan, Korea

²Medical Research Institute, Pusan National University, Busan, Korea

³Department of Laboratory Medicine, Asan Medical Center and University of Ulsan College of Medicine, Seoul, Korea

Received 28 November 200721 January 2008 Accepted 24 January 2008

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Background

Although hepatitis B surface antigen (HBsAg) rapid test based on immunochromatographic assay (ICA) is now widely used, the test has not been evaluated sufficiently enough to validate its performance. Thus, it is important to summarize the clinical performance of the test kits. In this study, we performed meta-analysis for the performance of the HBsAg rapid tests.

Methods

PubMed database was searched using keywords about the accuracy of diagnostic tests for hepatitis B virus (HBV) infection. Two investigators assessed methodological quality utilizing standards for reporting of diagnostic accuracy studies (STARD) checklist. After performing a heterogeneity test, we obtained pooled sensitivity and specificity. Positive and negative predictive values (PPV and NPV) were simulated according to HBV prevalence.

Results

A total of 38 studies was selected from 10 papers. The quality scores ranged from 3 to 13 (median, 8). Kappa value was good (0.85). The performance of the 38 studies was heterogeneous. When 33 studies with better quality from 7 papers were re-selected, the pooled sensitivity and specificity were 98.07% (95% confidence interval, CI: 97.67-98.47%) and 99.56% (95% CI: 99.21-99.91%), respectively. With an HBV prevalence of 5%, PPV and NPV were predicted to be 92.14% and 99.90%, respectively.

Conclusions

In view of high HBV prevalence in Korea, it is thought that the HBsAg rapid test can be used for HBV screening in small-sized laboratories or for epidemiologic studies. This study should be helpful in establishing a guideline for the proper performance evaluation of the HBsAg rapid tests.

Keywords: HBsAg, Rapid test, Performance evaluation, Meta-analysis

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Fig. 1.

Funnel plots for publication bias of sensitivities (A), and specificities (B).

Fig. 2.

Estimates of sensitivity and specificity of HBsAg rapid tests. Points indicate estimates of sensitivities (A) and specificities (B). Vertical lines are 95% confidence intervals for estimates.

Fig. 3.

Predictive values according to prevalence with pooled sensitivity (98.07%) and specificity (99.56%). The Y axis plot positive predictive value (PPV) (A), and negative predictive value (NPV) (B).

Table 1.

Literature survey on both sensitivity and specificity of HBsAg rapid test kits

Studies	References	Spectrum of patients	Reference standard	Test assay	TP	FN	FP	TN	Sn	Sp
Clement	[16]	403 patients with biopsy-proven chronic HBV infection, 295 healthy volunteers	MEIA	Binax NOW	402	1	2	293	99.8	99.3
WHO (1)	[12]	99 HBsAg positive, 178 HBsAg negative sera from patients	ELISA	Genedia HBsAg Rapid	98	1	0	277	99.0	100
WHO (2)				Doublecheck HBs Antigen	98	1	7	171	99.0	96.1
WHO (3)				Genelabs Diagnostics Rapid HBsAg test	98	1	5	173	99.0	97.2
WHO (4)				Hepacard HBsAg	98	1	4	174	99.0	97.8
WHO (5)				ImmunoComb II HBs Ag 90	98	1	8	170	99.0	95.5
WHO (6)				Serodia HBs	98	1	0	178	99.0	100
WHO (7)				Determine HBsAg	98	1	1	177	99.0	99.4
WHO (8)				Uni-Gold HBsAg	98	1	0	178	99.0	100
WHO (9)				HEP B STAT-PAK ULTRA FAST	98	1	0	178	99.0	100
Lien (1)	[17]	101 HBsAg seroreactive,	EIA	Determine HBsAg	117	0	0	211	100	100
Lien (2)		99 HBsAb seronegative,	EIA	Serodia HBs	112	5	0	211	95.7	100
Lien (3)		128 potential cross-reactive group	EIA	Dainascreen HBsAg	117	0	0	211	100	100
Akanmu	[18]	101 blood donors	ELISA	Binax NOW	7	1	0	93	87.5	100
Lau	[19]	2463 selected samples (827 frozen sera, 1011 fresh sera, and 625 whole blood samples)	EIA	Binax NOW	157	8	0	2,298	95.2	100
Sato	[20]	462 routine samples a representation of worldwide genotypes	EIA and RPHA	Dainascreen HBsAg	158	0	0	304	100	100
ICBS (1)	[13]		EIA	Determine HBsAg	143	3	0	200	98.0	100
ICBS (2)				HBsAg Line test	143	3	0	200	98.0	100
ICBS (3)		A, B, C, D, E, F and their corresponding variety of subtypes.		Acon HBsAg One Step	143	3	0	200	98.0	100
ICBS (4)				HBsAg Dipstick One Step test	142	4	0	200	97.3	100
ICBS (5)		This HBV positive panel is composed of: a) 146 individual HBsAg positive members, b) 200 individual non-infectious plasma units received from the American Red Cross in Washington D.C., U.S.A		HBsAg	143	3	0	200	98.0	100
ICBS (6)				HbsAg Cassette	142	4	0	200	97.3	100
ICBS (7)				Quick HBsAg test	142	4	0	200	97.3	100
ICBS (8)				Assure HBsAg rapid test	143	3	0	200	98.0	100
ICBS (9)				i+LAB HBsAG test	142	4	0	200	97.3	100
ICBS (10)				Quick Chaser HBsAg	143	3	0	200	98.0	100
ICBS (11)				One Step HBsAg Dipstick test	143	3	0	200	98.0	100
ICBS (12)				BioLine HBsAg Strip	143	3	0	200	98.0	100
ICBS (13)				SD BioLine HBsAg	143	3	0	200	98.0	100
ICBS (14)				HEP-CHECK-1	138	8	0	200	94.5	100
ICBS (15)				HEP-CHECK-1-STRIP	142	4	0	200	97.3	100
ICBS (16)				HepaScan HBsAg cassette type/HepaScan HBsAg strip type	143	3	0	200	98.0	100
Cha (1)	[7]	20 HBsAg-positive, 20 HBsAg-negative sera by MEIA	MEIA	SD BioLine HBsAg	13	7	0	20	65.0	100
Cha (2)				Asan Easy Test HBsAg	16	4	0	20	80.0	100
Cha (3)				Genedia HBsAg Rapid	17	3	0	20	85.0	100
Oh	[5]	150 HBsAg-positive, 100 HBsAg-negative sera by EIA	EIA	Genedia HBsAg Rapid	147	3	0	100	98.0	100
Whang (1)	[6]	100 HBsAg-positive, 100 HBsAg-negative sera by MEIA	MEIA	Daewoong rapid HBsAg	97	3	0	100	97.0	100
Whang (2)				Genedia HBsAg Rapid	97	3	0	100	97.0	100

Abbreviations: TP, true positive; FN, false negative; FP, false positive; TN, true negative; Sn, sensitivity; Sp, specificity; MEIA, microparticle enzyme immunoassay; EIA, enzyme immunoassay; RPHA, reverse passive hemagglutination assay.

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